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Remifentanil Versus Propofol for TCI Sedation of Patients Undergoing Gastrointestinal Endoscopic Procedures

Information source: Fundación Universitaria de Ciencias de la Salud
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Remifentanil (Drug); Propofol (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Fundación Universitaria de Ciencias de la Salud

Official(s) and/or principal investigator(s):
Luis A Muñoz, MD, Study Director, Affiliation: Fundacion Universitaria de Ciencias de la Salud
Luis E Reyes, MD, Principal Investigator, Affiliation: Fundacion Universitaria de Ciencias de la Salud


The purpose of this study was to compare remifentanil and propofol for sedation of patients during endoscopic gastrointestinal procedures.

Clinical Details

Official title: Remifentanil Versus Propofol With Target Controlled Infusion Effect Site for the Sedation of Patients During Gastrointestinal Endoscopic Procedures: Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Patient satisfaction

Secondary outcome:

Gastroenterologist satisfaction

Adverse events

Detailed description: The administration of sedation with target controlled infusion (TCI) systems could offer a safe alternative for the management of discomfort of patients undergoing endoscopic gastrointestinal procedures. However, what medication from those available for TCI would be the most appropriate is not known. Sixty-nine patients requiring a gastrointestinal endoscopic procedure were randomly assigned to receive a TCI effect site (e) of remifentanil (n=30) or propofol (n=39). The primary outcome was patient satisfaction. Secondary outcomes included gastroenterologist satisfaction, the proportion of adverse events between the two groups were compared (occurrence of cardiac arrhythmias, mild respiratory depression, major respiratory depression, bradycardia, hypotension, pain, nausea or vomiting, and lack of amnesia), and the level of consciousness.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


Inclusion Criteria:

- Patient undergoing elective higher, lower or mixed gastrointestinal endoscopy at

Hospital de San Jose, Bogota, between January and December 2010.

- Be between 18 and 70 years old.

- American Society of Anesthesiology Physical Status classification between 1 and 3.

- Provide written informed consent.

Exclusion Criteria:

- Patients with difficult airway indicators.

- Pregnant women.

- Patients with chronic pain.

- Chronic opioid or benzodiazepine users (>3 months).

- Allergy history to remifentanil or propofol or eggs.

- Psychoactive drug users.

- Smokers (> 5 cigarettes per day in the previous 3 months).

- Body mass index > 30.

Locations and Contacts

Fundación Universitaria de Ciencias de la Salud, Bogota 11001000, Colombia
Additional Information

Starting date: January 2010
Last updated: December 8, 2012

Page last updated: August 23, 2015

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